The safety data and main results of this Phase I pharmacokinetic (PK) study (EudraCT No: 2010-022007-22) have been reported earlier [ 5].
Demographic and main baseline characteristics of the safety data set according to symptomatic PAF control at inclusion are summarized in Table 1.
In the insulin-specific EMA guidance, the main focus of any clinical study gathering safety data is, as might be expected, the AE profile, but this includes experience of hypoglycemia and local (injection-site) tolerability.
Major bleeding was the main safety end point, although we also collected and analysed data on minor bleeding.
An independent data monitoring and safety committee assessed safety data.
According to the safety data sheet for the commonly used black toner that was issued by manufacture, the main components of the toners are polyester resin, carbon black, iron oxide, and a few other elements.
As a substantial number (n = 14) of conditional appraisals contained requests for efficacy and safety data going beyond those made by the EMA, these were further analysed to identify the main topics covered.
A summary of the clinical efficacy data from each of the main phase II and III trials of abatacept in RA is first presented, followed by cumulative quality of life and safety data.
"The early safety data are reassuring.
Its safety data are not publicly released.
